A regional external quality assessment scheme (REQAS) for anti-HIV serology aimed to objectively assess reliability and quality of HIV testing processes in the African region. This involved the distribution of proficiency testing (PT) panels to participating laboratories from 2002 to 2010. During the survey period; this included 16 distributions of PT panels to 49 laboratories in 30 countries; and the overall average score during the nine-year survey period was 98.9; with a frequency of accurate detection; of anti-HIV-1 and/or anti-HIV-2 antibodies in the PT panels; ranging from 93 to 100. Problems highlighted included lack of human resources and frequent stock outs of test kits; reagents and consumables for routine HIV testing. The design of the REQAS allowed appraisal of the reliability of anti-HIV serological testing methods utilised by laboratories for clinical assessment of patients and/or surveillance programmes. The REQAS was able to demonstrate that laboratories participating in the REQAS performed well and sustained their participation in the scheme. This bodes well for clinical diagnosis; surveillance and training activities at these reference laboratories.

A regional external quality assessment scheme (REQAS) for anti-HIV serology aimed to objectively assess reliability and quality of HIV testing processes in the African region. This involved the distribution of proficiency testing (PT) panels to participating laboratories from 2002 to 2010. During the survey period; this included 16 distributions of PT panels to 49 laboratories in 30 countries; and the overall average score during the nine-year survey period was 98.9; with a frequency of accurate detection; of anti-HIV-1 and/or anti-HIV-2 antibodies in the PT panels; ranging from 93 to 100. Problems highlighted included lack of human resources and frequent stock outs of test kits; reagents and consumables for routine HIV testing. The design of the REQAS allowed appraisal of the reliability of anti-HIV serological testing methods utilised by laboratories for clinical assessment of patients and/or surveillance programmes. The REQAS was able to demonstrate that laboratories participating in the REQAS performed well and sustained their participation in the scheme. This bodes well for clinical diagnosis; surveillance and training activities at these reference laboratories.

Objective: To determine if use of basic laboratory tests improves diagnosis and treatment outcomes in outpatients attending rural primary health care facilities. Setting: Six rural health centres in Kenya.Design: Cross-sectional study to observe change in diagnosis and treatment made by clinical officers after laboratory testing in outpatients attending six rural health centres in Kenya.Subject: The diagnosis and treatment of 1134 patients attending outpatient services in six rural health centres were compared before and after basic laboratory testing. Essential clinical diagnostic equipment and laboratory tests were established at each health centre. Clinical officers and laboratory technicians received on-site refresher training in good diagnostic practices and laboratory procedures before the study began. Results: Laboratory tests were ordered on 704 (62.1) patients. Diagnosis and treatment were changed in 45of tested patients who returned with laboratory results (21 of all patients attending the clinics). 166 (23.5 of all patients attending the clinics). 166 (23.5) patients did not return to the clinician for a final diagnosis and management decision after laboratory testing. Blood slide examination for malaria parasites; wet preparations; urine microscopy and stool microscopy resulted in most changes to diagnosis. There was no significant change in drug costs after laboratory testing. The greatest changes in numbers of recorded diseases following laboratory testing was for intestinal worms (53) and malaria (21). Conclusion: Effective use of basic laboratory tests at primary health care level significantly improves diagnosis and patient treatment. Use of laboratory testing can be readily incorporated into routine clinical practice. On-site refresher training is an effective means of improving the quality of patient care and communication between clinical and laboratory staff.

Objective: To determine if use of basic laboratory tests improves diagnosis and treatment outcomes in outpatients attending rural primary health care facilities. Setting: Six rural health centres in Kenya.Design: Cross-sectional study to observe change in diagnosis and treatment made by clinical officers after laboratory testing in outpatients attending six rural health centres in Kenya.Subject: The diagnosis and treatment of 1134 patients attending outpatient services in six rural health centres were compared before and after basic laboratory testing. Essential clinical diagnostic equipment and laboratory tests were established at each health centre. Clinical officers and laboratory technicians received on-site refresher training in good diagnostic practices and laboratory procedures before the study began. Results: Laboratory tests were ordered on 704 (62.1) patients. Diagnosis and treatment were changed in 45of tested patients who returned with laboratory results (21 of all patients attending the clinics). 166 (23.5 of all patients attending the clinics). 166 (23.5) patients did not return to the clinician for a final diagnosis and management decision after laboratory testing. Blood slide examination for malaria parasites; wet preparations; urine microscopy and stool microscopy resulted in most changes to diagnosis. There was no significant change in drug costs after laboratory testing. The greatest changes in numbers of recorded diseases following laboratory testing was for intestinal worms (53) and malaria (21). Conclusion: Effective use of basic laboratory tests at primary health care level significantly improves diagnosis and patient treatment. Use of laboratory testing can be readily incorporated into routine clinical practice. On-site refresher training is an effective means of improving the quality of patient care and communication between clinical and laboratory staff.

Issues: Quality-management systems (QMS) are uncommon in clinical laboratories in Nigeria; and until recently; none of the nation's 5 349 clinical laboratories have been able to attain the certifications necessary to begin the process of attaining international accreditation. Nigeria's Human Virology Laboratory (HVL); however; began implementation of a QMS in 2006; and in 2008 it was determined that the laboratory conformed to the requirements of ISO 9001:2000 (now 2008); making it the first diagnostic laboratory to be certified in Nigeria. The HVL has now applied for the World Health Organization (WHO) accreditation preparedness scheme. The experience of the QMS implementation process and the lessons learned there in are shared here. Description: In 2005; two personnel from the HVL spent time studying quality systems in a certified clinical laboratory in Dakar; Senegal. Following this peer-to-peer technical assistance; several training sessions were undertaken by HVL staff; a baseline assessment was conducted; and processes were established. The HVL has monitored its quality indicators and conducted internal and external audits; these analyses (from 2007 to 2009) are presented herein. Lessons learned: Although there was improvement in the pre-analytical and analytical indicators analysed and although data-entry errors decreased in the post-analytical process; the delay in returning laboratory test results increased significantly. There were several factors identified as causes for this delay and all of these have now been addressed except for an identified need for automation of some high-volume assays (currently being negotiated). Internal and external audits showed a trend of increasing non-conformities which could be the result of personnel simply becoming lax over time. Application for laboratory accreditation; however; could provide the renewed vigour needed to correct these non conformities. Recommendation: This experience shows that sustainability of the QMS at present is a cause for concern. However; the tiered system of accreditation being developed by WHO-Afro may act as a driving force to preserve the spirit of continual improvement.

Issues: Quality-management systems (QMS) are uncommon in clinical laboratories in Nigeria; and until recently; none of the nation's 5 349 clinical laboratories have been able to attain the certifications necessary to begin the process of attaining international accreditation. Nigeria's Human Virology Laboratory (HVL); however; began implementation of a QMS in 2006; and in 2008 it was determined that the laboratory conformed to the requirements of ISO 9001:2000 (now 2008); making it the first diagnostic laboratory to be certified in Nigeria. The HVL has now applied for the World Health Organization (WHO) accreditation preparedness scheme. The experience of the QMS implementation process and the lessons learned there in are shared here. Description: In 2005; two personnel from the HVL spent time studying quality systems in a certified clinical laboratory in Dakar; Senegal. Following this peer-to-peer technical assistance; several training sessions were undertaken by HVL staff; a baseline assessment was conducted; and processes were established. The HVL has monitored its quality indicators and conducted internal and external audits; these analyses (from 2007 to 2009) are presented herein. Lessons learned: Although there was improvement in the pre-analytical and analytical indicators analysed and although data-entry errors decreased in the post-analytical process; the delay in returning laboratory test results increased significantly. There were several factors identified as causes for this delay and all of these have now been addressed except for an identified need for automation of some high-volume assays (currently being negotiated). Internal and external audits showed a trend of increasing non-conformities which could be the result of personnel simply becoming lax over time. Application for laboratory accreditation; however; could provide the renewed vigour needed to correct these non conformities. Recommendation: This experience shows that sustainability of the QMS at present is a cause for concern. However; the tiered system of accreditation being developed by WHO-Afro may act as a driving force to preserve the spirit of continual improvement.

Background: The improvment of the quality of testing services in public laboratories is a high priority in many countries. Consequently; initiatives to train laboratory staff on quality management are being implemented; for example; the World Health Organization Regional Headquarters for Africa (WHO-AFRO) Strengthening Laboratory Management Towards Accreditation (SLMTA). Mentorship may be an effective way to augment these efforts.Methods: Mentorship was implemented at four hospital laboratories in Lesotho; three districts and one central laboratory; between June 2009 and December 2010. The mentorship model that was implemented had the mentor fully embedded within the operations of each of the laboratories. It was delivered in a series of two mentoring engagements of six and four week initial and follow-up visits respectively. In total; each laboratory received 10 weeks mentorship that was separated by 6-8 weeks. Quality improvements were measured at baseline and at intervals during the mentorship using the WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist and scoring system. Results: At the beginning of the mentorship; all laboratories were at the SLIPTA zero star rating. After the initial six weeks of mentorship; two of the three district laboratories had improved from zero to one (out of five) star although the difference between their baseline (107.7) and the end of the six weeks (136.3) average scores was not statistically significant (p = 0.25). After 10 weeks of mentorship there was a significant improvement in average scores (182.3; p = 0.034) with one laboratory achieving WHO-AFRO three out of a possible five star status and the two remaining laboratories achieving a two star status. At Queen Elizabeth II (QE II) Central Laboratory; the average baseline score was 44; measured using a section-specific checklist. There was a significant improvement by five weeks (57.2; p = 0.021). Conclusion: The mentorship programme in this study resulted in significant measurable improvements towards preparation for the WHO-AFRO SLIPTA process in less than six months. We recommend that mentorship be incorporated into laboratory quality improvement and management training programmes such as SLMTA; in order to accelerate the progress of laboratories towards achieving accreditation.

Background: The improvment of the quality of testing services in public laboratories is a high priority in many countries. Consequently; initiatives to train laboratory staff on quality management are being implemented; for example; the World Health Organization Regional Headquarters for Africa (WHO-AFRO) Strengthening Laboratory Management Towards Accreditation (SLMTA). Mentorship may be an effective way to augment these efforts.Methods: Mentorship was implemented at four hospital laboratories in Lesotho; three districts and one central laboratory; between June 2009 and December 2010. The mentorship model that was implemented had the mentor fully embedded within the operations of each of the laboratories. It was delivered in a series of two mentoring engagements of six and four week initial and follow-up visits respectively. In total; each laboratory received 10 weeks mentorship that was separated by 6-8 weeks. Quality improvements were measured at baseline and at intervals during the mentorship using the WHO-AFRO Strengthening Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist and scoring system. Results: At the beginning of the mentorship; all laboratories were at the SLIPTA zero star rating. After the initial six weeks of mentorship; two of the three district laboratories had improved from zero to one (out of five) star although the difference between their baseline (107.7) and the end of the six weeks (136.3) average scores was not statistically significant (p = 0.25). After 10 weeks of mentorship there was a significant improvement in average scores (182.3; p = 0.034) with one laboratory achieving WHO-AFRO three out of a possible five star status and the two remaining laboratories achieving a two star status. At Queen Elizabeth II (QE II) Central Laboratory; the average baseline score was 44; measured using a section-specific checklist. There was a significant improvement by five weeks (57.2; p = 0.021). Conclusion: The mentorship programme in this study resulted in significant measurable improvements towards preparation for the WHO-AFRO SLIPTA process in less than six months. We recommend that mentorship be incorporated into laboratory quality improvement and management training programmes such as SLMTA; in order to accelerate the progress of laboratories towards achieving accreditation.

Introduction: The Lesotho Ministry of Health and Social Welfare's (MOHSW) 5-year strategic plan; as well as their national laboratory policy and yearly operational plans; directly addresses issues of accreditation; indicating their commitment to fulfilling their mandate. As such; the MOHSW adopted the World Health Organization Regional Headquarters for Africa's Stepwise Laboratory Quality Improvement Toward Accreditation (WHO-AFRO-SLIPTA) process and subsequently rolled out the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme across the whole country; becoming the first African country to do so. Methods: SLMTA in Lesotho was implemented in two cohorts. Twelve and nineteen laboratory supervisors and quality officers were enrolled in Cohort 1 and Cohort 2; respectively. These 31 participants represented 18 of the 19 laboratories nationwide. For the purposes of this programme; the Queen Elizabeth II (QE II) Central Laboratory had its seven sections of haematology; blood bank; cytology; blood transfusion; microbiology; tuberculosis laboratory and chemistry assessed as separate sections. Performance was tracked using the WHO-AFRO-SLIPTA checklist; with assessments carried out at baseline and at the end of SLMTA. Two methods were used to implement SLMTA: the traditional 'three workshops' approach and twinning SLMTA with mentorship. The latter; with intensive follow-up visits; was concluded in 9 months and the former in 11 months. A standard data collection tool was used for site visits.Results: Of the 31 participants across both cohorts; 25 (81) graduated (9 from Cohort 1 and 16 from Cohort 2). At baseline; all but one laboratory attained a rating of zero stars; with the exception attaining one star. At the final assessment; 7 of the 25 laboratories examined at baseline were still at a rating of zero stars; whilst 8 attained one star; 5 attained two stars and 4 attained three stars. None scored above three stars. The highest percentage improvement for any laboratory was 51; whereas the least improved dropped by 6 when compared to its baseline assessment.The most improved areas were corrective actions (34) and documents and records (32). Process improvement demonstrated the least improvement (10). Conclusion: The SLMTA programme had an immediate; measurable and positive impact on laboratories in Lesotho. This success was possible because of the leadership and ownership of the programme by the MOHSW; as well as the coordination of partner support.

Introduction: The Lesotho Ministry of Health and Social Welfare's (MOHSW) 5-year strategic plan; as well as their national laboratory policy and yearly operational plans; directly addresses issues of accreditation; indicating their commitment to fulfilling their mandate. As such; the MOHSW adopted the World Health Organization Regional Headquarters for Africa's Stepwise Laboratory Quality Improvement Toward Accreditation (WHO-AFRO-SLIPTA) process and subsequently rolled out the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme across the whole country; becoming the first African country to do so. Methods: SLMTA in Lesotho was implemented in two cohorts. Twelve and nineteen laboratory supervisors and quality officers were enrolled in Cohort 1 and Cohort 2; respectively. These 31 participants represented 18 of the 19 laboratories nationwide. For the purposes of this programme; the Queen Elizabeth II (QE II) Central Laboratory had its seven sections of haematology; blood bank; cytology; blood transfusion; microbiology; tuberculosis laboratory and chemistry assessed as separate sections. Performance was tracked using the WHO-AFRO-SLIPTA checklist; with assessments carried out at baseline and at the end of SLMTA. Two methods were used to implement SLMTA: the traditional 'three workshops' approach and twinning SLMTA with mentorship. The latter; with intensive follow-up visits; was concluded in 9 months and the former in 11 months. A standard data collection tool was used for site visits.Results: Of the 31 participants across both cohorts; 25 (81) graduated (9 from Cohort 1 and 16 from Cohort 2). At baseline; all but one laboratory attained a rating of zero stars; with the exception attaining one star. At the final assessment; 7 of the 25 laboratories examined at baseline were still at a rating of zero stars; whilst 8 attained one star; 5 attained two stars and 4 attained three stars. None scored above three stars. The highest percentage improvement for any laboratory was 51; whereas the least improved dropped by 6 when compared to its baseline assessment.The most improved areas were corrective actions (34) and documents and records (32). Process improvement demonstrated the least improvement (10). Conclusion: The SLMTA programme had an immediate; measurable and positive impact on laboratories in Lesotho. This success was possible because of the leadership and ownership of the programme by the MOHSW; as well as the coordination of partner support.